CTRI/2019/04/018487已完成3 期
A Phase III, open label, randomized, multi-centric, active controlled, clinical trial to evaluate the immune response and safety of SIIPLâ??s Liquid Live Attenuated Human Seasonal Quadrivalent Influenza Vaccine (LAIV-LQ) and SIIPLâ??s Freeze Dried Live Attenuated Human Seasonal Trivalent Influenza Vaccine (LAIV-FD) among healthy Indian individuals equal to or more than 2 years of age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Normal healthy subjects of >= 2 years at the time of screening.
- •2.Parent of subject (2-17 years) willing to give written informed consent and willing to comply with study protocol
- •3.The subject (>=18 year) is willing to give informed consent and willing to comply with study protocol.
- •4.The subject (07-17 year) is willing to give informed assent and willing to comply with study protocol.
- •5.Free of obvious health problems as established by medical history, and physical examination.
- •6.The subject should be the resident of study area.
- •7.Female subject of child bearing potential must agree not to become pregnant and the male subject must agree not to conceive a child from the time of study enrolment until at least three months after the receiving the study vaccine
排除标准
- •1.Acute febrile illness
- •2.Acute infectious disease or had acute respiratory illness needing antibiotics or antivirals in the previous 7 days (temporary exclusion criteria)
- •3.Active allergic rhinitis (temporary exclusion criteria)
- •4.Active wheezing (temporary exclusion criteria)
- •5.Children or adolescents (2-17 years of age) receiving aspirin therapy or aspirin-containing therapy in the previous 7 days (temporary exclusion criteria)
- •6.History of influenza infection within one year prior to day of vaccination
- •7.History of vaccination against influenza within one year prior to day of vaccination
- •8.Have a known allergy to eggs or other components of the vaccine (including gelatin, sorbitol, lactalbumin and chicken protein).
- •9.Women with positive urine pregnancy test within 24 hours prior to vaccination, or women who are breastfeeding or are unwilling to undergo pregnancy testing.
- •10. Participating in other clinical trial or planned participation in another clinical trial during their entire trial period.
- •11. Altered immune status or chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying agents within six months prior to administration of study vaccine.
- •12. History of severe allergic reaction with generalized urticaria, angioedema or anaphylaxis.
- •13. History of Guillain-Barré Syndrome.
- •14. Major congenital defects or serious chronic illness
- •15. Receipt of licensed vaccine, immune sera and/or any blood products, or an investigational study agent within previous 30 days or planned during their participation in the study
- •16. Acute or chronic, clinically significant pulmonary, endocrine, autoimmune, psychiatric, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and/or physical examination, which in the opinion of the investigator might interfere with the study objectives
- •17. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer participating in the study or make it unlikely that the subject could complete the protocol
研究者
相似试验
进行中（未招募）
1 期
A phase III, multicentric, Randomized, open-label, parallel-group clinical trial to detect false positives from first-trimester preeclampsia screening (StopPRE) at the second-trimester of pregnancy.First-trimester pre-eclampsia patientsMedDRA version: 20.0Level: PTClassification code 10036485Term: Pre-eclampsiaSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditionsEUCTR2018-000811-26-ESVall D'Hebron Institut de Recerca (VHIR)1,080
已完成
3 期
A Phase III study to evaluate the immunogenicity, reactogenicity and safety of ROTAVAC 5CM compared with existing ROTAVAC® in healthy infants aged 6-8 weeksCTRI/2016/11/007481Bharat Biotech International Limited360
进行中（未招募）
1 期
A phase 3, randomized, open-labeled, multi-center study comparing clinical efficacy and safety of intravenous sarilumab plus standard of care compared to standard of care, in the treatment of patients with severe COVID-19 pneumonia .Covid-19 coronavirus infectionMedDRA version: 20.1Level: HLTClassification code 10047468Term: Viral lower respiratory tract infectionsSystem Organ Class: 100000004855EUCTR2020-001390-76-ITISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE LAZZARO SPALLANZANI171
招募中
1 期
ot applicableEUCTR2010-019952-35-ITCEL-SCI Corporation880
进行中（未招募）
1 期
A Phase III Study of the Effects of Multikine on Cancer of the Oral CavityEUCTR2010-019952-35-HRCEL-SCI Corporation1,273